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http://www.nti.org/d_newswire/issues/2005_7_7.html#B8EA5D14

Half of U.S. Military Personnel Refuse Anthrax Shot

By David Ruppe
Global Security Newswire

WASHINGTON — Half of U.S. military and civilian personnel offered anthrax vaccinations under a voluntary program that began in May have refused the inoculation, according to figures released yesterday to Global Security Newswire by a Defense Department agency (see GSN, May 6).

Since May 19, the vaccine has been offered to about 14,000 personnel, and roughly 7,000 of them have refused to take it, according to Col. John Grabenstein, director of the Military Vaccine Agency.

No explanation was given for the high number of refusals. “We can’t speculate on individual decisions,” he said.

The current pace of vaccinations is expected to increase, he said, as additional clinic workers are certified to give the vaccine and additional military units offer treatments to personnel.

The high refusal rate comes amid persisting complaints by some service people and nongovernmental experts that the U.S. military has been reluctant to acknowledge a connection between the vaccine and uncommon but potentially debilitating side effects, which they say has hindered access to medical benefits and compensation (see GSN, Nov. 16, 2004).

It comes also despite a determination in December by then-Deputy Defense Secretary Paul Wolfowitz, citing classified intelligence, that there is “a significant potential for a military emergency involving a heightened risk” of an anthrax attack on U.S. forces.

Wolfowitz’s finding preceded the Food and Drug Administration’s granting of an emergency legal authority in January to give the vaccine voluntarily to service people. The vaccinations are focused on personnel stationed for prolonged periods in South Korea and the area of the U.S. Central Command, which includes the Middle East, along with those deployed for special biodefense-related missions.

“We are concerned that those who decline vaccination could die or be harmed if attacked with anthrax spores,” Grabenstein said.

The military has maintained that the vaccine is as safe as other commonly used vaccines, and Grabenstein said the recent treatments have produced only minor side effects.

“Adverse events are similar to previous experience, primarily temporary injection-site pain, swelling, or redness,” he said.

Steve Robinson, executive director of the National Gulf War Resource Center, however, said officials have been reluctant to acknowledge severe side effects that sometimes occur, making it difficult to obtain proper medical support.

The refusal rate, he said, suggests “that soldiers are not willing to take the risk if [the Defense Department] is not willing to provide medical care and compensation should they become injured.”

Approximately 1,200 military personnel were treated in 2003 and 2004 by four special clinics called Vaccine Healthcare Centers, for complex reactions to the anthrax or other military vaccines, the Army told Global Security Newswire this year (see GSN, May 6).

Mandatory Vaccinations Could Resume

The vaccinations began May 19. Under the voluntary program, personnel cannot be punished for refusing the vaccine.

A mandatory anthrax vaccination program that began months before the March 2003 invasion of Iraq and inoculated more than 1 million personnel was halted last October. The decision came after a federal judge ruled the vaccine could not be mandatory because the Food and Drug Administration had not licensed it as effective against inhalation anthrax, the type soldiers most be most likely to face in the field. Personnel who refused then were subject to possible removal from deployment status and disciplinary action.

A licensing decision is pending from the Food and Drug Administration for using the vaccine against inhalation anthrax, which could lead to renewed mandatory vaccinations. A final period for public comment ended in March.

The refusal rate appears to resemble that experienced by the voluntary anthrax vaccination program administered by the British government prior to and during the Iraq war. Statistics made public by the British Defense Ministry in February 2003 showed that as many as 49 percent of 20,000 military personnel offered anthrax vaccinations prior to the Iraq did not accept.

“The [Defense Ministry] is clearly losing the battle to convince the armed forces that anthrax infection is a clear and present danger in the Gulf,” MP Paul Keetch, Liberal Democrat shadow defense secretary, said then. “When weighing the risks of infection with fear of health complications from the vaccine, the majority of RAF [Royal Air Force] and naval personnel are rejecting vaccination.”

A former officer from the Royal British Legion, a charity supporting British service people and veterans, said in September 2004 that statistics indicated then that one-third of an estimated 45,000 British personnel involved in the invasion had refused anthrax vaccinations, according to a report by the Guardian.

A Canadian judge in May 2000 ruled Canadian military personnel could refuse the vaccinations without penalty, questioning that vaccine’s safety.

More than 40 Australian soldiers reportedly were recalled from Iraq around the time of the invasion for refusing anthrax vaccinations, though they reportedly were not disciplined.

The Bush administration justified the invasion of Iraq as necessary primarily for removing an alleged threat posed by a suspected Iraqi nuclear weapons program, and alleged chemical and biological weapons, including anthrax. A CIA-sponsored team concluded last year Iraq no longer had such weapons, having abandoned its banned programs after the 1991 Gulf War.

The terrorist network al-Qaeda is believed to have sought to use anthrax, but failed to obtain the agent or full capability for producing a weapon before it was routed from Afghanistan in late 2001. 

A Defense Department report in 2001 alleged that North Korea had pursued biological weapons capabilities since the 1960s and possessed a rudimentary technical infrastructure capable of producing anthrax and other biological warfare agents. That same report alleged Iran had an active biological warfare program.

Anthrax mailings to several U.S. Senate offices and news media organizations in fall 2001 killed five people and sickened 22. No one has been caught.

GSN staff writer David Francis contributed to this article

One needs to wonder where COL. Grabenstein has been the past 6 + years, remarks made through entire article should almost be embarrassing.

1.             RE: No explanation was given for the high number of refusals. “We can’t speculate on individual decisions,” he said.

This has been previously stated in GAO testament that IF the anthrax vaccination program was voluntary, there would be few takers, see: http://www.gao.gov/new.items/d02445.pdf; page 14 of the report for those that would not take the shot if voluntary; those who already left service, or had plans to BECAUSE OF AVIP begin on page 9.

2.             Re: “We are concerned that those who decline vaccination could die or be harmed if attacked with anthrax spores,” Grabenstein said.

From the US Medical Research, Institute of Infectious Disease, Ft. Detrick, July 1998: (Email copy available on request – Thanks Z)

Treatment: Although effectiveness may be limited after symptoms are present, high dose antibiotic treatment with penicillin, ciprofloxacin, or doxycycline should be undertaken. Supportive therapy may be necessary.

PROPHYLAXIS

Vaccine: A licensed vaccine is derived from sterile culture fluid supernatant taken from an attenuated strain. The vaccination series consists of six 0.5 ml doses SC at 0, 2, and 4 weeks, then 6, 12 and 18 months, followed by yearly boosters. Limited human data suggest that the vaccine protects against cutaneous anthrax. There is insufficient data to know its efficacy against inhalational anthrax in humans, although studies in rhesus monkeys indicate that good protection can be afforded after only two doses (15 days apart) for up to 2 years.

3.           Re: “The military has maintained that the vaccine is as safe as other commonly used vaccines, and Grabenstein said the recent treatments have produced only minor side effects.”

http://www.nti.org/d_newswire/issues/2005/5/6/325532e2-159e-459b-b667-4df3b804ebaf.html

Military Vaccines Trigger Special Treatment for 1,200

WASHINGTON — Approximately 1,200 U.S. military personnel who received vaccinations against biological agents during the past two years developed complex, in some cases debilitating, illnesses that were assessed or treated by a specialized network of clinics, according to figures released to Global Security Newswire by the U.S. Army and a review of some cases

http://www.nti.org/d_newswire/issues/2004/5/18/b047b91a-baae-4469-a369-ce894037d5a1.html

Since the headquarters center opened in 2001 at Walter Reed Army Medical Center in Washington, the network has evaluated more than 1,000 patients — military personnel, contractors and civilians — and counseled far more personnel — 139,000 in fiscal 2003 alone — by telephone and e-mail, according to Engler.

Suggestions have been made to close down some of the four centers, each of which has 12 clinical staff members, but the centers are overwhelmed, Engler said.

The network lately has been researching several cases of blistering skin rashes and oral ulcers, identified as the rare disease “pemphigus vulgarus,” occurring after anthrax vaccinations. It also is aiding investigations of at least 71 cases of myopericarditis occurring following smallpox vaccinations (see GSN, May 13). 

Congress created the network following revelations in the late 1990s that the anthrax vaccine was causing a significant number of serious illnesses among military personnel, said Meryl Nass, another prominent military vaccine critic and physician who regularly treats soldiers with suspected vaccination complications.

“Congress pointed out that people, who were becoming ill following vaccinations, needed to be treated appropriately within the military, not just discharged because of their medical disability,” she said.

“We’ve briefed over the last few months numerous venues, and everyone says you’re doing a good job, we need you. … People continue to apologize to us and say we know you’re a good thing, we just don’t know how to pay for you,” she said. (COL. Engler)

http://www.bioportcorp.com/AnthraxVaccine/insert/avainsert.asp

Pregnancy
PREGNANCY CATEGORY D., See Warnings.

Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening. The serious adverse events most frequently reported were in the following body system categories: general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue disorders, and musculoskeletal, connective tissue and bone disorders. Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax. None of these hypersensitivity reactions have been fatal.

Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.

Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).

4.             Re: The refusal rate, he said, suggests “that soldiers are not willing to take the risk if [the Defense Department] is not willing to provide medical care and compensation should they become injured.”

Unlike Waxman’s bill for civilians, see: http://www.nti.org/d_newswire/issues/2003/2/28/7s.html

WASHINGTON — Public health experts said this week that the single largest factor preventing implementation of the U.S. smallpox immunization plan is the lack of compensation for those sickened by the vaccine, but legislation is now being drafted to address the problem, according to congressional sources. 

Waxman’s Bill

Waxman’s bill proposes a “no-fault compensation program modeled on the existing childhood Vaccine Injury Compensation Program.  The purpose of this bill is to compensate people … for their un-reimbursed medical expenses and lost wages,” according to a summary of the bill released by Waxman’s office.

And Senator Gregg’s urging, see: http://www.nti.org/d_newswire/issues/2003/3/7/8s.html

The legislation would provide $262,100 to vaccine recipients, or their families, who die or suffer permanent disability.  It would also provide limited compensation, after five missed days of work, for those who suffer less serious side effects.

“People should certainly sign up because this legislation is going to pass,” Gregg said.

Military personnel don’t quite have the same luxury of compensation for injuries incurred while on active duty (status all need to be on while being administered vaccinations), courtesy of the FERES doctrine: (Thanks to Jeff Trueman for the extract of FERES in his book titled “Beyond the Scope of Justice).  “FERES doctrine was born in December 1947, when 1st Lt Randolph Feres died in a fire in an Army barracks at Pine Camp, NY. Believing that the fire was caused by a defective heating plant, his widow sued the U.S. Three years later, in 1950, the Supreme Court dismissed her suit. Explaining the majority opinion, Justice Robert Jackson said that members of the armed services may not sue the government for death or injury resulting from activities "incident to service".   As a result of this case, this has set precedent that medical malpractice, experimentation, accidental injury, anything that the government (to include Federal Employees) does to its men and women in uniform, can be done with no accountability to those that did the deed, as well as no justice for the member, and/or their family.